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Regulation (EU) 2024/3110 CHAPTER V — TECHNICAL ASSESSMENT BODIES

Article 38–Article 41 · 4 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Designating authorities

Article 38

1.   Member States wishing to designate TABs shall designate a single designating authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and designation of TABs. Designating authorities shall satisfy the requirements for notifying authorities set out in Articles 43(1) and Article 44. Member States may designate the notifying authority referred to in Article 43, as the designating authority. The designating authority shall not be eligible for designation in accordance with Article 39(1). 2.   Unless otherwise specified in this Chapter, the provisions applicable to notifying authorities and to notification procedures apply also to designating authorities and to the designation procedures.

Designation, monitoring and evaluation of TABs

Article 39

1.   Member States may, through their designating authorities, designate TABs within their territories for one or several product families listed in Annex VII. Member States may also designate TABs within their territories as competent for emerging or innovative products that do not fall into already existing product families listed in Annex VII. Member States shall communicate the name of the TAB, its address and the product family or families it is competent for to the Commission. 2.   The Commission shall assign an identification number to each TAB. The Commission shall make publicly available the list of TABs designated under this Regulation by electronic means and indicate their identifications numbers, the product families for which they are designated and any limitations in the most precise possible way. The Commission shall ensure that that list is kept up-to-date. 3.   The designating authority shall monitor the activities and competence of the TABs designated in their respective Member State, and where necessary their subsidiaries and subcontractors, and evaluate them in relation to the respective requirements set out in this Chapter. The designating authority shall impose corrective measures on TABs wherever there is an infringement of this Regulation. Member States shall inform the Commission of their national procedures for the designation of TABs, of the monitoring of their activity and competence, and of any changes to that information. 4.   TABs shall, without delay, and at the latest within 15 days, inform the designating authority of any changes which may affect their compliance with the requirements set out in this Chapter or their ability to satisfy their obligations under this Regulation. 5.   TABs shall, at the request of the relevant designating authority, supply all relevant information and documents, required to enable that authority, the Commission and the Member States to verify their compliance with the requirements under this Regulation. 6.   Where a TAB no longer complies with the requirements of this Regulation, the designating authority shall restrict, suspend or withdraw the designation of that TAB for the relevant product family as appropriate, depending on the seriousness of the failure to meet those requirements. Where a TAB has repeatedly not complied with corrective measures imposed in accordance with paragraph 3 of this Article, the designating authority may restrict, suspend or withdraw the designation of that TAB. The designating authority shall inform the Commission and the other Member States of any restriction, suspension or withdrawal of a designation. Articles 53(2) and 54 shall apply.

Requirements for TABs

Article 40

1.   A TAB shall be competent, and equipped, to carry out the assessment in relation to the product families for which it has been designated. The decision-making staff and at least half of the technical competent staff shall be employed by the TAB under the national law of the designating Member State. 2.   The TAB shall satisfy the requirements set out in Annex VIII, within the scope of its designation. Article 46(2) to (5), Article 46(6), points (a) and (b), Article 46(7), (8), (9) and (11) and Article 47 shall apply. 3.   A TAB shall have made publicly available its organigram and the names of the members of its internal decision-making bodies. 4.   A TAB shall participate in the activities of the organisation of TABs or ensure that their assessment personnel is informed about those activities.

Coordination of TABs

Article 41

1.   The TABs shall establish an organisation for technical assessment (‘organisation of TABs’) under this Regulation. 2.   The organisation of TABs shall at least carry out the following tasks: (a) supply the Commission with relevant technical content relating to European assessment documents when the development of harmonised technical specifications based on the same product families is due to take place in accordance with the working plan referred to in Article 4(2). That information shall be based on close collaboration with the relevant European standardisation organisations; (b) organise the coordination of the TABs and, if necessary, ensure cooperation and consultation with other stakeholders; (c) ensure that examples of best practice are shared between TABs to promote greater efficiency and provide a better service to industry; (d) develop and adopt European assessment documents; (e) coordinate the application of the procedures set out in Article 59(2), Article 60(2) and in Article 61(2), as well as provide the support needed to that end; (f) inform the Commission of any question related to the preparation of European assessment documents and of any aspects related to the interpretation of the procedures set out in Article 60(2) and in Article 61(2) and suggest improvements to the Commission based on experience gained; (g) communicate any observations concerning a TAB not satisfying its tasks in accordance with the procedures set out in Article 60(2) and in Article 61(2) to the Commission and the Member State which designated the TAB; (h) report annually to the Commission on: (i) the fulfilment of the tasks referred to above; (ii) the allocation of European assessment document development tasks to the TABs; (iii) the even geographic distribution of tasks between TABs; (iv) the European technical assessments issued for each European assessment document including the geographical distribution of TABs involved and of the manufacturers receiving the documents; and (v) the performance and the independence of TABs; and; (i) ensure that adopted European assessment documents and references to European technical assessments are kept publicly available. The organisation of TABs shall set up a secretariat in order to carry out these tasks. 3.   Member States shall ensure that the TABs contribute adequately with financial and human resources to the organisation of TABs. Organisation of TABs shall establish the contribution of each TAB which shall be proportionate taking into account the annual budget or turnover of each TAB related to its activities as TAB. 4.   The weight in the decision-making process of the organisation of TABs shall not depend on the TABs’ financial contribution, the number of European assessment documents developed or the number of European technical assessments issued by them. 5.   The Commission shall be invited to participate in all meetings of the organisation of TABs. 6.   Union financing may be granted to the organisation of TABs for the implementation of the tasks referred to in paragraph 2. The Commission may make the financing of the organisation of TABs, whether by way of grants or public tenders, subject to the fulfilment of certain organisational and performance requirements set out in those tasks.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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